The present invention relates to apparatus for safely transporting an implantable intraocular lens from the manufacturing facility to the implanting physician, and more particular to an intraocular lens case that minimizes the handling of the intraocular lens between the time it is initially manufactured and the time it is prepared for the implanting procedure.
Intraocular lenses are manufactured in a variety of configurations. All, however, include an optical portion (optic) carrying two or more positioning loops (haptics) that extend outwardly from the optic. These loops are generally composed of monofilament polymeric materials that are adhesively or otherwise affixed to the optics.
Currently, once a lens is manufactured, it is placed in a case in which it resides during quality control, measurement, and sterilization procedures prior to shipment to a customer. The lens usually remains in the case between the time it is shipped and the time it is removed from the case in preparation for the implanting procedure.
In the past, intraocular lenses have been placed in conventional contact lens cases for handling and shipment. Merely placing them in a contact lens case has allowed the lenses to be dropped, lost or damaged in handling. As a consequence, the lenses of at least one manufacturer have been placed in a holder that comprises a small cup-like member. The cup-like member has a flat bottom surface with a zone of weakness running diametrically across its bottom surface. A pair of posts extend upwardly on each side of the zone of weakness. The posts each carry two sets of opposing detents that are separated by 6.0 mm and 5.0 mm respectively. Intraocular lenses depending on size are placed in one of the sets of detents by flexing the cup-like member along its zone of weakness, thus causing the posts to be spread apart. The lens can then be dropped into place while the cup-like member is allowed to flex back to its original position to securely hold the intraocular lens in the lens receiving detents. This cup-like holder is normally positioned in an ordinary contact lens case during the manufacturing procedures and subsequent shipping.
This cup-like holder does eliminate the need to directly handle the lens except for a final inspection and in preparation for implanting the lens. Once the lens is positioned in the holder, however, the holder must be inserted in and removed from the contact lens case several times prior to shipment. For example, it must be removed from the contact lens case in order to inspect the lens for loop tip-to-loop tip dimensional tolerance, which is usually done with the aid of an optical comparator. Once the dimensional tolerance is checked, the holder and associated lens can again be placed in the contact case and the lid closed. The lens case is then moved to a next quality control station where a power reading is taken. In order to take the power reading, the lens holder must be removed from the case, measured and returned to the case. Lastly, at a final inspection, the lens and holder are again removed from the contact lens case, the holder flexed to remove the lens so that it can be visually inspected. Once the visual inspection is complete, the cup-like holder is again flexed, the lens inserted and the lens and holder returned to the contact lens case. Thereafter, the case holder and lens are placed in a sterilized bag and are subjected to a sterilization procedure after which they are prepared for shipment.
To prepare the lens for use, the lens case is first removed from the sterilized bag and the lens holder is removed from the lens case. This procedure is done either by a physician or an operating room technician. If the physician or technician is not familiar with the use and operation of the lens holder, removal of the lens from the lens holder is sometimes attempted by grasping a loop with a foreceps and attempting to pull the lens from the case, more likely than not separating the loop from the optic, but not removing the lens from the holder. As a consequence, the lens is rendered unusable.
It is therefore desirable to place the lenses in a case that eliminates much of the lens case and holder manipulation during manufacture as well as eliminates the possibility of damage to a lens upon removal from the case.